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Researcher Resources

Conduct Study

What are my responsibilities during the study?

  1. Manage Budgeting & Billing
  2. Resources for Budgeting & Billing
  3. Requesting Help with Enrollment, Ethics & More
  4. Review Regulatory & Compliance Documents

For detailed information, open the color-coded items below this key.

CTSI users receiving services are required to:
  • Cite the CTSI grant UL1TR001881 in CTSI-supported research.
  • Complete periodic CTSI surveys

GUIDANCE - Consult with a Study Facilitator

CTSI provides Research Facilitators who connect investigators to the resources needed at any stage of the clinical research process.

    Contact your site Research Facilitator

Budgeting & Billing — Overview of CTRC Services

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  • Learn more or submit a UCLA CTRC application
  • Contact your site below to learn how to submit your application. All CTRC partner site services are available to all CTSI researchers.

Clinical and Translational Research Budgeting and Billing

The UCLA Clinical and Translational Research Centers (CTRCs) assist investigators with:

  • set-up of your CTRC study budget
  • obtain CTRC cost information
  • ensure proper billing of all patient care activities

If your research will be completed at a Clinical and Translational Research Center, please see the CTRC application process below.

What is the CTRC application?

The UCLA CTRC online application processes and forms are used at UCLA-Westwood, Cedars-Sinai, Charles R. Drew University and LA BioMed/Harbor-UCLA to submit, review, and approve clinical research services. See below for the available processes and forms at each site: All CTRC partner site services are available to all CTSI researchers.

See below for the available processes and forms at each site:

UCLA-Westwood CTRC

Cedars-Sinai CTRC

Charles R. Drew University CTRC

LA BioMed/Harbor-UCLA CTRC

Support for Research Budgets

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See the below resources to get more information on how to approach budgeting and billing on clinical research projects.

UCLA

Clinical Research and Clinical Trial activity at UCLA involves coordination of many areas and departments within the Medical Sciences enterprise and on the UCLA campus. The Office of Compliance Services created resources for the research community as it relates to conducting research in a responsible manner and in compliance with the applicable federal and state laws and regulations.

Support for Research Participant Billing

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CTRCs

The CTSI Clinical and Translational Research Centers (CTRCs) at UCLA-Westwood, Cedars-Sinai, Charles R. Drew University and LA BioMed/Harbor-UCLA, provide budget and billing support to faculty conducting research at the CTSI partner sites (Cedar-Sinai Medical Center, Charles R. Drew University, Harbor-UCLA at LA BioMed and UCLA).

UCLA

Clinical Research Billing for the CTRC
Clinical Research and Clinical Trial activity at UCLA involves coordination of many areas and departments within the Medical Sciences enterprise and on the UCLA campus. The Office of Compliance Services created resources for the research community as it relates to conducting research in a responsible manner and in compliance with the applicable federal and state laws and regulations. More »

Government Resources

Key Points

  • Keep accurate, complete, up-to-date records (including enrollment status).
  • Review and return billing reports in a timely manner.

Obtaining Medical Record Data to Conduct Your Research

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  • Questions?

If you need access to electronic medical records for research purposes you should use the below directory of information for the four CTSI institutions and contact the appropriate research facilitator (at right) with follow up questions.

Obtain Medical Record Data to Conduct Your Research

The CTSI Biomedical Informatics Program (BIP) provides investigators with the services for obtaining medical record data to conduct their research. Learn how to obtain a data consult, obtain IRB approval, obtain compliance approval and receive data extractions and deliveries.

To see all services available regarding clinical data requests, click here.

What is an Electronic Health Record (EHR)?

An Electronic Health Record (EHR) is a systematic collection of electronic health information about individual patients or populations. Records may include a whole range of data in comprehensive or summary form, including demographics, medical history, medication and allergies, immunization status, laboratory test results, radiology images, vital signs, personal statistics like age and weight, and billing information.

  • UCLA – uses CareConnect, an implementation of the Epic EMR system
  • Cedars-Sinai – uses CSLink, which is also an implementation of the Epic EMR system
  • Charles R. Drew University – is affiliated with several clinical and health centers that use a variety of EMR systems
  • LA BioMed – is affiliated with Harbor-UCLA Medical Center, which is implementing ORCHID based on the Cerner EMR system

Do I need IRB approval to Access Data from Electronic Health Records?

Yes, you will need IRB approval, but what sections are checked off on your IRB will differ depending on the type of data set you are accessing. You need to have patient authorization with a written HIPAA authorization form, or an approved waiver of HIPAA authorization from the IRB/Privacy Board, to review health records for research purposes. The IRB process differs depending on if you are accessing: 1) de-identified data or 2) comprehensive patient data or in identifying candidates for clinical research studies. For more information, please review the IRB website at your UCLA CTSI institution. IRB websites are found here under "IRB Approval".

UCLA Electronic Health Records (CareConnect)

    How do I view EHR at a partner CTSI institution?

    If accessing patient records outside of the data repositories (i.e. UC ReX, LADR or xDR), an investigator will require a collaborator from the partner institution to carry out the responsibility for accessing the partner institute’s patient's medical records in order to meet the HIPPA Privacy Rule. This activity requires prior IRB/Privacy Board approval.

    Request an Ethics Consultation

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    The CTSI Regulatory Knowledge and Support, and Ethics Program provides consultations relating to the ethics of research including help with informed consents, evaluation of population vulnerabilities, assisting with protocol design, and provision of ethics requirements related to specific grant proposals. Confidential consultations are also provided for interpersonal research-related issues including referrals to institutional support services.

    Ethics consultations for patient-related health care matters are handled independently of the CTSI at each partner institution. See contacts at right for available resources.

    Request Patients for Clinical Trials

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    • Questions?
    • Contact LA BioMed/Harbor-UCLA for more information on eligibility and usage

    LA BioMed/Harbor UCLA offers ResearchMatch which brings together people who are trying to find research studies, and researchers who are looking for people to participate in their studies. Many studies are looking for healthy people of all ages, while some are looking for people with specific health conditions.

    The ResearchMatch registry is free and secure, and anyone can join.

    ResearchMatch is a Clinical and Translational Science Awards (CTSA) initiative funded by the National Center for Research Resources, a part of the NIH.

    Regulatory & Compliance – Support Services, Resources and QuickLinks

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    The Regulatory Knowledge and Support, and Ethics Program services include:

    Post-Approval Regulatory Oversight (PARO)

    Data Safety Monitoring

    • Develop and review data safety monitoring plans
    • Review data safety monitoring reports
    • Adverse event and incident reporting

    Quality Assurance

    • Review data collection forms
    • Monitor studies

    Regulatory Requirements

    • Continuing regulatory review and approval
    • Conflicts of interest
    • Clinical trial registration
    • Progress reports

    QuickLinks

    Regulatory & Compliance – Documentation

    • Document Management and Storage
      Please Follow the links below for information about on-campus data-storage options.
      • UCLA: Guidance on the proper handling of information technology, including personal information, can be found in the UC Policies for Information Technology.
      • Cedars-Sinai Medical Center: coming soon.
      • LA Biomed/Harbor-UCLA Medical Center: Information Systems & Technology, Director, Mark Sleet (310) 222-6519 msleet@labiomed.org
      • Charles R. Drew University of Medicine and Science: not applicable at this time.
    • Download Sample (IND)
    • Download Sample (IDE)

    Budgeting & Billing Training

    next steps

    See the below resources to get more information on how to approach budgeting and billing on clinical research projects.

    UCLA

    Clinical Research and Clinical Trial activity at UCLA involves coordination of many areas and departments within the Medical Sciences enterprise and on the UCLA campus. The Office of Compliance Services created resources for the research community as it relates to conducting research in a responsible manner and in compliance with the applicable federal and state laws and regulations.

    Required Training for Clinical Research

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    • Questions?

    Education, required training and professional growth opportunities are available to the clinical research communities at the CTSI partner sites.

    REQUIRED TRAINING

    UCLA

    • Collaborative Institutional Training Initiative (CITI)* (Required)
      Required human subjects training for all key personnel who work on research projects (all investigators and other study personnel, including all persons who are responsible for the design, conduct, data analysis or reporting). More »
    • Laboratory Safety Fundamental Concepts (Required)
      Everyone in the UCLA community is required to take some safety training. To clarify what safety training is necessary for each job function, Environmental Health and Safety developed the Training Requirements online tool, including the Lab Safety Training Matrix, for determining what safety training UCLA employees and students needs to take. More »
    • HIPAA Training (Required)
      The HIPAA Research training is a module of the Protecting Human Research Subjects online training site. This site requires registration and login. Questions should be directed to Office of Compliance Services. More »

    Recommended Training for Clinical Research

    next steps

    • Questions?

    UCLA

    • webIRB Training
      webIRB is an online application used at UCLA to submit, review, and approve research (human subjects; stem cells; animal subjects; and biosafety). More »
    • webIRB Education Program
      Basic and Advanced didactic training for webIRB users. More »
    • GCP Training through Office of the Human Research Protection Program
      If you are new to research or just need a refresher course, Good Clinical Practice (GCP) offerings are available through OHRPP. More »
    • Clinical Research Billing
      Clinical Research and Clinical Trial activity at UCLA involves coordination of many areas and departments within the Medical Sciences enterprise and on the UCLA campus. The Office of Compliance Services created resources for the research community as it relates to conducting research in a responsible manner and in compliance with the applicable federal and state laws and regulations. More »

    Education/Workshops

    next steps

    • Questions?

    • CTSI Training Program in Translational Science
      Provide clinicians and fellows with the necessary training to become successful patient-oriented investigators who can bridge molecular medicine and clinical research. The program has undergone extraordinary growth since its founding in 2000 to support the development and enhancement of core courses and in-depth training necessary for mastery of the fundamental skills, methodologies, theories, and conceptualizations of translational clinical investigation. More »
    • CTSI Responsible Conduct of Research Courses
      This course provides a thorough background in the ethical issues in research with emphasis on research involving humans. Discussion of current issues in responsible conduct of clinical research, including reporting of research, basis for authorship, issues in genetic research, principles and practice of research on humans, conflicts of interest, Institutional Review Board (IRB), and related topics. More »
    • Find a Workshop
      View upcoming educational workshops offered by CTSI and affiliates. More »
    • Workshop archive
      View past CTSI-supported workshops. More »

    Other Training Resources

    next steps

    • Questions?

    UCLA

    • CareConnect training – UCLA Electronic Health Record Program
      Training is required for all UCLA Hospital and Clinics physicians and medical personnel who need access to Hospital Medical Records. Training is completed online. The specific courses that you are required to complete are dependent on your specialty, sub-specialty and scope of clinical practice. More »
    • Biomedical Library
      The Louise M. Darling Biomedical Library supports clinical and research clientele on a variety of topics. Unless otherwise noted, sessions are open; no advance registration is required. More »
    • Tech Training
      The Office of Information Technology (OIT) at UCLA provides technology courses. See the ITS website for training options in the classroom and online. More »
    • STAR Program
      The Specialty Training and Advanced Research (STAR) Program at the David Geffen School of Medicine at UCLA is a unique program designed for optimal training of physician-scientists. The program offers the opportunity to combine clinical fellowship or residency training with formal, advanced research training. More »
    • UCLA Clinical Trials Administration Office
      The Clinical Trials Administration Office provides the latest news and clinical trials information for the UCLA Jonsson Comprehensive Cancer Center and other departments. More »
    • Office of Intellectual Property and Industry Sponsored Research
      Pre- and post-award administration of sponsored projects to the University. More »

    Professional Development

    next steps

    • Questions?

    PROFESSIONAL DEVELOPMENT

    • ACRP
      ACRP is the primary resource for clinical research professionals in the pharmaceutical, biotechnology and medical device industries, and those in hospital, academic medical centers and physician office settings. More »
    • UC Berkeley Extension
      UC Berkeley Extension offers a Certificate Program in Clinical Research Conduct and Management which enables you to master practical aspects of clinical trial conduct and management, including clinical trial phases and design, planning, implementation, data analysis, regulatory and procedural guidelines, and ethical considerations. More »
    • UC Santa Cruz Extension
      The UCSC Extension Certificate in Clinical Trials Design and Management is designed to help professionals gain a solid understanding of the entire clinical trials process, as well as a foundation in the scientific principles, regulations, and ethics that are vitally important to the conduct of clinical research. More »
    • UC San Diego Extension
      Since its inception in 1997, with the help of a highly-qualified and prestigious advisory board & instructors who are cutting-edge industry professionals, UC San Diego Extension’s Professional Certificate in Clinical Trial & Design Management trains professionals at all levels in this vibrant and stimulating field. Students are able to customize their program by choosing an emphasis of study through a grouping of “topics” for a mastery of skills in diverse clinical trial areas. More »
      The UCSD Extension Specialized Certificate in Clinical Trials Administration is modeled on the top-rated UCSD Extension Professional Certificate in Clinical Trials Design and Management, the premier 200+ hour series of courses. The Intensive program consists of more than 100 hours of instruction through two sections, combining classroom instruction as a cohort and distance learning courses to be completed at your place of residence. More
    • San Francisco State University Extension
      Through the Clinical Trial Design and Management Certificate Program students may complete a full certificate or simply take those courses which advance their own professional goals. The program is designed to be flexible for working adults by offering evening or weekend courses. More »
    • Society of Clinical Research Associates
      SOCRA is a non-profit, charitable and educational membership organization committed to providing education, certification, and networking opportunities to all persons involved in clinical research activities. SOCRA, the premier educational organization for oncology site coordinators, has now emerged as a leading educational organization for clinical researchers in all therapeutic areas, supporting industry, government and academia. More »

    HIPAA Training

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    The Health Insurance Portability and Accountability Act (HIPAA) – Each person at the CTSI partner sites must be aware of the obligations imposed by HIPAA and the Privacy and Security Rules. See below for each site’s policy and training information.

    UCLA

    HIPAA Training (Required)
    The HIPAA Research training is a module of the Protecting Human Research Subjects online training site. The site, accessible here, requires registration and login.

    Collaborative IRB Training Initiative (CITI)

    next steps

    • Questions?

    Collaborative Institutional Training Initiative (CITI) training is required human subjects training for all staff working on a research project (all investigators and other study personnel, including all persons who are responsible for the design, conduct, data analysis or reporting of a research project).

    UCLA

    CITI Training (Required)
    Required human subjects training for all key personnel who work on research projects (all investigators and other study personnel, including all persons who are responsible for the design, conduct, data analysis or reporting).

    • Register for Training
      This is the UCLA Office of the Human Research Protection Program (OHRPP) website. Site includes link to the CITI website to register for training, completion check list and FAQs.

    Clinical Research Training

    next steps

    • Questions?
    • CTSI Training Program in Translational Science
      Provide clinicians and fellows with the necessary training to become successful patient-oriented investigators who can bridge molecular medicine and clinical research. The program has undergone extraordinary growth since its founding in 2000 to support the development and enhancement of core courses and in-depth training necessary for mastery of the fundamental skills, methodologies, theories, and conceptualizations of translational clinical investigation. More »
    • CTSI Responsible Conduct of Research Courses
      This course provides a thorough background in the ethical issues in research with emphasis on research involving humans. Discussion of current issues in responsible conduct of clinical research, including reporting of research, basis for authorship, issues in genetic research, principles and practice of research on humans, conflicts of interest, Institutional Review Board (IRB), and related topics. More »
    • Find a Workshop
      View upcoming educational workshops offered by CTSI and affiliates. More »
    • Workshop archive
      View past CTSI-supported workshops. More »

    UCLA

    Online clinical research training is available at UCLA Health Sciences Training Portal. Access the following courses:

    • Division of Laboratory Animal Medicine Training Website
    • Environment, Health and Safety Online Learning Center
    • Office of Research Administration Contract and Grant Administration Training
    • UCLA Online Training: Protection of Human Research Subjects Training Certificates & HIPAA Clinical Research Training Certificates

    For a list of UCLA Research Resources, click here.

    Mentoring Support for Junior Investigators

    For mentoring and career development opportunities at UCLA CTSI partner sites, please see below.


    Clinical Contacts

    Good Clinical Practice

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    Good Clinical Practice (GCP) is an international ethical and scientific quality standard, published by the International Conference on Harmonization (ICH), an international body that defines standards, which governments can transpose into regulations for clinical trials involving human subjects.

    Good Clinical Practice guidelines include the protection of human rights, safety and welfare during clinical trials. They also assure clinical data integrity.

    Good Clinical Practice guidelines include standards on how clinical trials should be conducted; and define the roles and responsibilities of clinical trial sponsors, clinical research investigators and monitors.

    Useful Links

    Education and Training

    CTSI Courses

    • UCLA CTRC (Clinical and Translational Research Center) Research Networking Seminars
      The CTRC is offering monthly informal clinical research networking seminars to bring together faculty and staff, hear invited experts speak, discuss topics of current interest, and exchange best practices/solutions to common clinical research challenges. All members of the clinical research community are welcome and invited to attend. If you are interested in attending these monthly sessions (4th Thursday), please contact Dr. Laurie Shaker-Irwin lshakerirwin@mednet.ucla.edu to receive further information and to be placed on the e-mail list. View the CTSI Events calendar for details and topics.
    • Responsible Conduct of Research Courses
      This course provides a thorough background in the ethical issues in research with emphasis on research involving humans. Discussion of current issues in responsible conduct of clinical research, including reporting of research, basis for authorship, issues in genetic research, principles and practice of research on humans, conflicts of interest, Institutional Review Board (IRB), and related topics. More »

    UCLA

    • Collaborative Institutional Training Initiative (CITI)
      Required human subjects training for all key personnel who work on research projects (all investigators and other study personnel, including all persons who are responsible for the design, conduct, data analysis or reporting). More »
    • GCP Training through Office of the Human Research Protection Program
      If you are new to research or just need a refresher course, Good Clinical Practice (GCP) offerings are available through OHRPP. More »

    Other Resources

    Related Videos

    Roles & Responsibilities – Budgeting

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    PI and/or Study Coordinator

    • Determines study eligibility for Medicare NCD.
    • Identifies patient care costs in the study that are routine care versus research costs to be paid by the sponsor.
    • Determines the level of effort required for study personnel to execute a study.
    • Identifies the locations where the research related items will be performed.
    • If study qualifies under NCD, works with clinical trials office to determine if any research costs can be billed to insurance.
    • Consults with hospital ancillary services experts to correctly analyze feasibility, identify protocol required procedures and to schedule study subjects with hospital specialty areas.
    • May need to provide patient information for unusual or complex procedures in order to obtain billing reports.
    • For device studies, prepares Medicare FI preauthorization packet for submission.
    • Acquires prices from available databases or Hospital Departments.

    Clinical and Translational Research Centers

    UCLA-Westwood

    • Review approved protocol, IRB application, consent
    • Assist with acquiring pricing from available databases or Hospital Departments
    • Establishes discounts for research prices.
    • Provides pricing information as needed.

    OTHER RESOURCES

    UCLA

    • For research budget/billing concerns, see the Clinical Research Billing FAQ page
    • Office of Clinical Trials
      • Reviews sponsor payment schedule and contract.
      • Meets with PI/Study Coordinator to evaluate protocol, obtain budget information, and review payment terms.
      • Obtains waivers as needed.
      • Negotiates budget and payment terms with sponsor.
      • Revises payment schedule to match approved and negotiated budget.
      • Revises internal budget as needed to match sponsor award.